Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00074802
First received: December 19, 2003
Last updated: September 18, 2008
Last verified: September 2008
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Purpose
This study will determine whether the addition of cognitive behavioral therapy can improve the effectiveness of the medication paroxetine (Paxil®) in treating individuals with social anxiety disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Social Anxiety Disorder |
Drug: Paroxetine Behavioral: Cognitive behavioral therapy (CBT) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CBT Augmentation of Paroxetine for Social Anxiety |
Resource links provided by NLM:
MedlinePlus related topics:
Anxiety
Drug Information available for:
Paroxetine
Paroxetine hydrochloride
Paroxetine hydrochloride hemihydrate
Paroxetine Mesylate
U.S. FDA Resources
Further study details as provided by National Institute of Mental Health (NIMH):
Primary Outcome Measures:
- Liebowitz Social Anxiety Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Social Interaction Anxiety Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
- Sheehan Disability Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
- Quality of Life Inventory [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
- Clinical Global Impression Improvement Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
| Enrollment: | 153 |
| Study Start Date: | December 2003 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive treatment with paroxetine
|
Drug: Paroxetine
Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Other Name: Paxil
|
|
Experimental: 2
Participants will receive treatment with paroxetine plus cognitive behavioral therapy
|
Drug: Paroxetine
Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Other Name: Paxil
Behavioral: Cognitive behavioral therapy (CBT)
CBT will consist of 16 weekly treatment sessions.
|
Detailed Description:
Social anxiety disorder is a prevalent and disabling condition for which effective long-term treatments need to be identified. Paroxetine is effective in treating the acute symptoms of social anxiety, but longer-term management remains a challenge. Cognitive behavioral therapy (CBT) has been effective in treating depression and panic disorder symptoms; it may also be effective in augmenting paroxetine response and reducing relapse after medication discontinuation. This study will examine the effects of paroxetine treatment alone and in combination with CBT.
Participants in this study will receive paroxetine for 12 weeks. After 12 weeks, participants will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks. After the 16-week treatment period, participants will have their treatments tapered and will be followed for an additional 24 weeks. Social anxiety symptoms, rates of remission, and quality of life will be assessed.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- DSM-IV criteria for generalized social phobia
- Willing and able to give written informed consent
- English-speaking
Exclusion Criteria:
- Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders
- Suicidal thoughts
- History of failed paroxetine treatment of at least 6 weeks' duration at adequate doses or a history of failed outcome of a previous adequate trial of CBT
- Clinically significant and/or unstable medical disease
- Pregnancy or breast-feeding. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study through the use of an effective method of contraception.
- Alcohol or substance abuse or dependence within the past 3 months. Patients with a positive drug screen but no substance abuse disorder will be eligible for the study, provided they have not met criteria for abuse/dependence within the last 6 months and provide two clean urine samples 2 weeks apart.
- Current or past history of seizure disorder (except febrile seizure in childhood)
- Conditions that contraindicate the use of paroxetine
- Inability to tolerate or unwillingness to accept a drug-free period of 4 weeks for monoamine oxidase inhibitors (MAOIs) or fluoxetine and 2 weeks for other selective serotonin reuptake inhibitors (SSRIs), neuroleptics, antidepressants, benzodiazepines, mood stabilizers, buspirone, beta-adrenergic blockers, or other psychotropic drugs prior to beginning the study
- Currently receiving psychotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074802
Locations
| United States, New York | |
| New York State Psychiatric Institute Anxiety Disorders Clinic | |
| New York, New York, United States, 10032 | |
| United States, Pennsylvania | |
| Adult Anxiety Clinic of Temple University | |
| Philadelphia, Pennsylvania, United States, 19122-6085 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Richard Heimberg, PhD | Adult Anxiety Clinic of Temple University |
| Principal Investigator: | Michael Liebowitz, MD | New York State Psychiatric Institute Anxiety Disorders Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Richard Heimberg, Principal Investigator, Temple University |
| ClinicalTrials.gov Identifier: | NCT00074802 History of Changes |
| Other Study ID Numbers: | R01 MH64481, DSIR 83-ATAS, R01 MH64726, GSK ID: 101618 |
| Study First Received: | December 19, 2003 |
| Last Updated: | September 18, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Social Phobia |
Additional relevant MeSH terms:
|
Anxiety Disorders Phobic Disorders Mental Disorders Paroxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013